"This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments," FDA Commissioner Margaret Hamburg, MD, said in a news release. "But ... it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit."
No study has shown that Avastin helps breast cancer patients live longer or improve their quality of life. However, one early study suggested that it might improve survival by about half a year. Later studies did not fully confirm this possible benefit, according to the FDA's analysis.
Genentech had been planning a new study of Avastin in breast cancer patients. But that would not be completed before 2016. The company said today it fully intends to complete the study as well as other ongoing studies of avastin and breast cancer.
"I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug," Hamburg said at a news conference.
In addition to Avastin's common side effects of nosebleed and severe high blood pressure, serious side effects include: massive bleeding; perforation of the nose, stomach, and intestines; blood clots; heart attack; kidney damage; wounds that do not heal; and a condition called RPLS that is characterized by headache, confusion, seizures, and vision loss.
Despite these risks, many women facing metastatic breast cancer have petitioned the FDA to retain their access to Avastin. Without FDA approval, Avastin might not be reimbursed by insurance companies -- or by Medicare/Medicaid. The wholesale price of Avastin is $7,500 a month, which does not include infusion costs. The FDA is not allowed to consider cost in its approval decisions.
"We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States," Hal Barron, MD, Genentech chief medical officer, says in a news release.